The following data is part of a premarket notification filed by Ladd Research Industries, Inc. with the FDA for Mini-monitor J7000 Icp.
| Device ID | K893395 |
| 510k Number | K893395 |
| Device Name: | MINI-MONITOR J7000 ICP |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | LADD RESEARCH INDUSTRIES, INC. P.O. BOX 1005 Burlington, VT 05402 |
| Contact | John Arnott |
| Correspondent | John Arnott LADD RESEARCH INDUSTRIES, INC. P.O. BOX 1005 Burlington, VT 05402 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-01 |
| Decision Date | 1989-11-22 |